The following data is part of a premarket notification filed by Airstrip Technologies, Inc. with the FDA for Airstrip Rpm For Lifenet Consult.
Device ID | K121712 |
510k Number | K121712 |
Device Name: | AIRSTRIP RPM FOR LIFENET CONSULT |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | AIRSTRIP TECHNOLOGIES, INC. 335 E Sonterra Blvd Ste 200 San Antonio, TX 78258 |
Contact | Robert A Miller |
Correspondent | Robert A Miller AIRSTRIP TECHNOLOGIES, INC. 335 E Sonterra Blvd Ste 200 San Antonio, TX 78258 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-11 |
Decision Date | 2012-11-20 |